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United States. Food and Drug Administration

Anteris Receives FDA Approval for PARADIGM Trial to Evaluate DurAVR(R) THV Compared to Commercial TAVR Devices

Strategic Insights

— 1 min read

Anteris, a global structural heart company, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a global Investigational Device Exemption (IDE) clinical trial, known as the PARADIGM Trial. This prospective randomized controlled trial will evaluate the safety and effectiveness of the DurAVR(R) Transcatheter Heart Valve (THV) designed for physiologic flow compared to commercially available TAVR devices. The PARADIGM Trial is co-chaired by Dr. Michael J. Reardon and Professor Stephan Windecker, and will enroll approximately 1000 patients across the United States, Europe, and Canada.

Key Takeaways:

  • The PARADIGM Trial is a prospective randomized controlled trial (RCT) that will evaluate the safety and effectiveness of the DurAVR(R) THV compared to commercially available TAVR devices.
  • The trial will enroll approximately 1000 patients across the United States, Europe, and Canada in the 'All Comers Randomized Cohort' with 1:1 randomization of patients who will receive either the DurAVR(R) THV or TAVR using commercially available and approved THVs.
  • The primary composite endpoint of the trial will be a non-inferiority comparison of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure.
  • The trial is designed to provide the robust clinical evidence required to support a future Premarket Approval (PMA) application in the United States and CE Mark approval in parallel.
  • The PARADIGM Trial will be conducted in accordance with the principles of Good Clinical Practice and will be overseen by an Institutional Review Board (IRB).

Statistics:

  • The PARADIGM Trial will enroll approximately 1000 patients across the United States, Europe, and Canada.
  • The trial will have a 1:1 randomization of patients who will receive either the DurAVR(R) THV or TAVR using commercially available and approved THVs.
  • The primary composite endpoint of the trial will be a non-inferiority comparison of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure.
  • The trial is expected to provide the necessary data to support a future PMA application in the United States and CE Mark approval.

Sources:

  • Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) - Anteris receives FDA approval to initiate PARADIGM Trial, GlobeNewswire, Nov. 03, 2025
  • ClinicalTrials.gov (ClinicaTrials.gov ID NCT07194265) - PARADIGM Trial - A Prospective Randomized Trial Assessing the Safety and Effectiveness of the DurAVR(R) THV Compared to Commercial TAVR Devices.

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